Electrical gastro-intestinal tract stimulator

ABSTRACT

The invention relates to medicine specifically to medical technology, and concerns electrical gastro-intestinal tract and mucous membrane stimulators. The electrical gastro-intestinal tract stimulator comprises a casing ( 1 ) with electrodes and in the form of a medicinal capsule containing a power source ( 4 ), a control unit ( 5 ) of which M outputs are connected to M electrodes ( 3 ), a device ( 6 ) for receiving signals from internal organs and/or an external transmitter, to (1-N) outputs of which are connected (1-N) inputs of the control unit ( 5 ). The electrical stimulator can contain P additional electrodes ( 7 ) provided with a coating of microelements or medicinal preparations and connected to P separate outputs of the control unit ( 5 ). The electrical stimulator can also contain a signal transmitter ( 10 ) designed to transmit signals from the device ( 6 ) for receiving signals from internal organs and/or external transmitter and control unit ( 5 ) to an external receiver for medical observation and monitoring. The dimensions of the electrical stimulator are restricted by the requirement that it be capable of being introduced into the gastro-intestinal tract orally or rectally or suitable for vaginal use.

The present application is a U.S. National Stage application claimingthe benefit of prior filed International Application, serial numberPCT/RU97/00091, filed Mar. 28, 1997, which International Applicationclaims a priority date of Apr. 1, 1996 based on prior filed RussianApplication serial number RU96/106244.

AREA OF ENGINEERING

The invention relates to medicine, specifically to medical technologyand can be used for electrical stimulation of organs ofgastro-intestinal tract (GIT) and mucous membranes in abdominal surgeryand for treatment of therapeutic type diseases.

BACKGROUND OF THE INVENTION

There is known in the art an apparatus with biocontrol, used inexperimental researches (see M. A. Sobakin and V. A. Shepelev “Furtherinstrumental-methodical electrical stomach stimulation providing withuse of a feedback principle”, /Experimental surgery andanesthesiology/—1973, vol. 2, p26), wherein pulses were sent at eachpositive phase of a patient's own biopotential, as received fromimplanted electrodes. A disadvantage of the described method ofelectrical GIT stimulation is the restriction of its sphere ofapplication, which is possible only [at operated sick person] with asurgery patient, and this person must be connected to the equipment.

There is known an electrical stimulator EGS-35-1 “ENDOTON-1”, it hasdimensions of 395×305×100 mm and a weight of 3 kgs (see “Electricalgastro-intestinal tract stimulation”, Moscow, “Medicine”, 1978, A. A.Vishnevsky, A. V. Livshitz, M. P. Vilyansky). In this book the modernprinciples and techniques of electrical GIT organs stimulation aredescribed. This and other external electrical GIT stimulators use a setof electrodes, one of which is a rectal or duodenal probe-electrode,other is a cutaneous one, or one bipolar electrode. A disadvantage ofthis kind of electrical stimulator is that the patient during a sessionof electrical stimulation is bound to electrical stimulator by wires,therefore, the application of electrical stimulators of that kindoutside of medical establishment is difficult.

There is also known a probe-stimulator for prolonged influence on astomach and sections of GIT within the reach of a length of connectingdrain (patent RU No. 1223922, MKI A61 N 1/36, published Bulletin ofInventions of Russia (BIR) No. 14, 1986). Its disadvantage is a limitedsphere of application, in that only out-patient and clinical applicationis possible.

There is also known an electrical stimulator containing a pulsegenerator, power source, electrodes, and an electrode-anode entirelycovered by a conductive film of microelements with thickness no lessthan 10 microns (patent RU No. 2036671, MKI 61 N 1/36, published BIR No.16, 1995). A disadvantage of this invention is that the microelementsfrom the film run within the whole length of GIT, nor does it provideenough selectivity in treatment, or feedback between a GIT condition andthe subjective sensations of a patient. This restricts the applicationof the electrical stimulator. On the other hand, it would beadvantageous if produced models of electrical stimulators typically didnot rely on such films, that complicates their application.

The most close in technical essence to the offered invention is anelectrical GIT stimulator containing electrodes, and having twoelectrical isolated parts of a medicinal capsule, where the pulsegenerator and power source are placed, and which capsule is capable ofmoving autonomously the full length of the gastro-intestinal tract, andto influence by electrical pulses the whole length of the GIT (patent RUNo. 936931 MKI A61 N 1/36, published BIR No. 23, 1982). Autonomouselectrical GIT stimulator can accomplish a positive effect in treatmentand prophylaxis of various diseases (see “Autonomous electricalstimulators of an organism of human and animals” Pekarsky V. V. andother, Siberian Medical University (SMU), Tomsk 1995, “Autonomouselectrical GIT stimulation” Dambaev G. C. and other, Siberiangastroenterology and gepatology magazine, October 1996, V 1, No. 2).However, because of the lack of a feedback mechanism to control theoperational or electrical stimulation parameters of the device inresponse to a condition in GIT organs relative to the subjectivesensations of a patient (e.g., pains and muscular convulsions arising atpassage of the device through some sections of GIT) and the limitedparameters of electrical stimulation of GIT, there are a number ofside-effects which contra-indicate use of the '931 device.

SUMMARY OF THE INVENTION

The object and main problem, solved by the offered invention, is animproved autonomous electrical GIT stimulator, for treatment andprevention of certain gastro-intestinal diseases. Another object is theautonomous electrical GIT stimulator having a feedback mechanism tocontrol the operational or electrical stimulation parameters of thedevice in response to the subjective sensations of a patient regardingthe condition of his/her internal organs. The incorporation of afeedback element provides for control of the electrical stimulator andan opportunity to change parameters of pulses according to a method oftreatment, or to the subjective sensations of a patient during use ofthe GIT stimulator device. This is to say that the feedback element isprovided as a mechanism to control the stimulator device from outsidethe patient's body, and to change the pulse parameters emitted by thedevice according to a specific treatment regimen, according to thesubjective sensations of a patient his or herself, when trained in useof the GIT stimulator device. It is also an optional feature of theoffered invention to increase the efficiency of a treatment regimen bythe controlled release of prescribed microelements or preparations(drugs) from the stimulator device by an electrochemical means as itpasses through the appropriate sections of the GIT. To increase theconvenience of such use of the device replaceable electrodes withcoatings of prescribed microelements or medicinal preparations can beinstalled on the device by the patient.

Another object of the electrical GIT is a receiver device and a controlunit. The receiver device receives signals from internal organs (of theGIT) and/or an external transmitter. The outputs (1 to N) of thereceiver device are connected to the inputs of the control unit. Thecontrol unit, based on a hardware or a program algorithm, sends a seriesof pulses to the M-electrodes of the electrical stimulator, depending onthe signals (from the internal organs and/or the external transmitter)coming in from the receiver device.

Another object of the offered invention is a feedback mechanism thesubjective sensations of the patient and the parameters of electricalstimulation of the GIT organs. The feedback mechanism is accomplished byadding sensors of signals to the receiver device. Signal sensors are forreceiving signals from an external transmitter, from the internal GITorgans or from both. Feedback between the GIT organs and the stimulatorof the physiological parameters of the GIT organs is used to adjust orcorrect the parameters of electrical pulses from the stimulatordepending on the changes in the physiological parameters of the GIT. Thereceiver device may contain sensors for: pressure, a gradient(difference) of pressure, pH, acoustics, temperature, biopotential, andconductivity of stimulated tissue. Therefore, the present stimulator mayadjust its output pulse parameters in response to feedback received fromthe sensors or by way of an external signal transmitted, for example, bythe patient in response to subjective sensation.

To further increase treatment efficiency, the offered invention includesthe installation of additional P-electrodes of selected microelements ormedical preparations as required, into a section of the GIT stimulator.The additional P-electrodes have a coating of microelements or medicinalpreparations, and are connected to the separate outputs of the controlunit. In keeping with the purpose of improved treatment and prevention,and for convenience of use, replaceable P-electrodes are used in theoffered electrical GIT stimulator. The additional P-electrodes can becarried out as demountable or replaceable by a user of the device.

The offered electrical GIT stimulator, comprises a casing in the form ofa medicinal capsule and having surface electrodes. The casing containinga power source, a control unit, outputs connected to M-electrodes, areceiving device having outputs connected to inputs of a control unit,and a control unit. The dimensions and the shape or form of electricalstimulator are limited by the requirement of its introduction intogastro-intestinal tract orally or rectally, or of its vaginal use.

The receiver device receives signals from the internal GIT organs, anexternal transmitter or from both. The receiver device comprises sensorsfor sensing physiological parameters of motor evacuative function andcurrent condition of GIT organs, and also signals from an externaltransmitter, the outputs of which being inputs of the receiver device.The sensors of the receiver device for receiving signals from internalGIT organs include: a sensor of pressure, a sensor of pressure gradient,a pH-sensor, an acoustic sensor, a sensor of temperature, a sensor ofbiopotential, a sensor of conductivity. Alternatively, the electrodes ofthe electrical stimulator can be used as the electrodes of the sensor ofbiopotential and of the sensor of conductivity.

The offered electrical stimulator in addition contains a signaltransmitter having inputs which are connected to the outputs of thereceiver device, and to a separate output of the control unit.

The control unit in the best embodiment contains a micro-controller. Themicro-controller has analog-digital amplifier circuits the inputs ofwhich are connected from the receiving device through the amplifiers tothe outputs of the micro-controller device, its outputs being the Moutputs of the control unit. Accordingly, the outputs of the controlunit are connected to the M-electrodes of electrical stimulator.Likewise, the additional outputs of the micro-controller, being theoutputs of the control unit, are connected to the additionalP-electrodes.

The main positive effect, which autonomous electrical GIT stimulatorshave is their ability to restore the motor-evacuative function of theGIT. The offered electrical GIT stimulator, in contrast to what isknown, is capable not only to move autonomously through thegastro-intestinal tract, but also to selectively influence GIT sites byintermittently applying electrical pulses to the sites, consecutivelyrestoring functions of organs along the whole length of the GIT. Alongwith the positive effect of autonomous electrical stimulation of theoffered stimulator on GIT organs already proved experimentally and in awide clinical practice, the application of the offered electricalstimulator gives a new opportunity to selectively and purposefullyinfluence by electrical stimulation specific sections and organs of GIT.This new opportunity to increase treatment efficiency is owing to theability to introduce prescribed medicinal preparations and microelementsto the necessary GIT sections by an electrochemical way or means. Theopportunity to adjust the pulse parameters of the autonomous electricalstimulator depends on a condition of internal organs appearing as asubjective sensation of a patient. Also, the opportunity to select modesof autonomous electrical stimulation depends on the character of adisease and from a current condition of GIT motor activity, and fromother parameters indicative of a condition of GIT organs detected by thesensors.

The above named purposes, characteristics and advantages of the presentinvention will be more clear from the following detailed description,which is accompanied by the appropriate drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan cut-away view which represents a construction ofthe offered electrical gastro-intestinal tract stimulator.

FIG. 2 is a block diagram of the offered electrical GIT stimulator.

FIG. 3 is a block diagram of the control unit in the simplest embodimentwith an external control input.

FIG. 4 is a block diagram of the control unit in the embodiment with GITactivity tracking and with external control inputs.

FIG. 5 is a block diagram of the control unit in the embodiment withmultichannel tracking for condition of GIT organs and for receivingsignals of external control for correlation with parameters ofelectrical stimulation.

DETAILED DESCRIPTION OF EMBODIMENTS

Referring now to the drawings, the details of preferred embodiments ofthe present invention are graphically and schematically illustrated.Like elements in the drawings are represented by like numbers, andsimilar elements are referred to by like numbers with a letter suffix.

As shown in FIG. 1, the offered electrical GIT stimulator 10 isconstructed in the shape of a medicinal capsule and configured to beadministered orally to a patient. Referring to FIG. 1, the offeredinvention comprises a housing or casing 12, a power source 16, a controlunit 18, a signal transmitter 14, and a signal receiver 22. The casing12 has M-electrodes 30 and P-electrodes 40 exposed on the outer surfaceof the casing 12, and a dielectric bushing 20 for electrically isolatingthe various electrodes and components of the stimulator 10. The powersource 16 in the embodiment shown in FIG. 1 is a series of batteries 16a. The power source 16 is connected to the control unit 18 by springcontact electrical connections 17 a & 17 b. FIG. 2 is a block schematicshowing the interconnection of the major components of the offeredstimulator 10. The batteries 16 a of the power source 16 are connectedto the control unit 18. The control unit 18 has a plurality ofcontroller/M-electrode connection 32 connecting it to a plurality ofM-electrodes, and a plurality of controller/P-electrode connections 34connecting it to a plurality of P-electrodes. The control unit may havemore outputs to the electrodes than are shown as actually connected inthe figures. Additionally the controller unit has acontroller/transmitter connection 36 to the signal transmitter. Thecontrol unit 18 has controller/receiver connections 38 between itselfand the signal receiver device 22. There may be more connection pointsbetween the controller and the signal receiver unit 22 than areconnections 38 actually shown in the figures. The dimensions and shapeof electrical GIT stimulator 10 are limited by the need to introduce itinto a patient's gastro- intestinal tract orally or rectally, or forvaginal use.

In the simplest embodiment, (FIG. 3) the control unit 18 contains afiltering circuit 50 having an input, connected to an output of thereceiver device 22 and an output connected to an input of an amplifierlimiter 56. An output of the amplifier limiter 56 is an output of thecontrol unit 18 and is connected to a first M-electrode 30 of theelectrical stimulator 10. The common buss or system ground is connectedto a second M-electrode 30 a.

Another embodiment of the control unit 18 (FIG. 4) comprises anintegrator circuit 52, an input of which is an input of the control unit18 and is connected to an output of the receiver device 22. An output ofthe integrator 52 is connected to an input of threshold circuit 54. Anoutput of the threshold circuit 54 being connected to an input of an“OR”-circuit 58. An output of the “OR”-circuit 58 is connected to acontrol input of the pulse series generator 60. Outputs of the pulsegenerator 60 are the outputs of the control unit 18 connected to theM-electrodes 30 a which communicates the pulse series to the GIT organs.The control unit 18 contains a first and a second filtering circuits 62& 63, having a common input from themselves from a second input of thecontrol unit 18. The inputs to the filter circuits 62 & 63 connected incommon to a second output of the receiver device 22. A second input ofthe “OR” circuit 58 is connected to the output of an RS trigger circuit66. The RS trigger circuit 66 has a “Set” input S which is connected toan output of a filter circuit 62, and a “Reset” input R connected to anoutput of a filter circuit 63.

In the best embodiment (FIG. 5) the control unit 18 comprises amicro-controller 80, 1 to N analog-digital inputs through amplifiers 82,are connected respectively to 1 to N outputs of the receiver device 22.1 to M outputs of the micro-controller 80 are connected to correspondingM-electrodes 30 of the electrical stimulator 10. The additional 1 to Poutputs of the micro-controller 80, being 1 to P outputs of the controlunit 18, are connected to the P-electrodes 46.

The electrical GIT stimulator works as follows. It is introduced intogastro-intestinal tract orally or rectally. Pulse series withaverage-statistical characteristics are sent from the control unit 18 tothe M-electrodes 30 a. The receiver device 22 registers data ofphysiological activity of GIT—i.e. about arising peristaltic waves.These data are transmitted to inputs of the control unit 18. Havingachieved sufficiently high motor activity of GIT, which is characterizedby certain amplitude and frequency of a voltage, coming from the sensorof pressure or from the sensor of biopotential (criteria of estimationand parameters of pulses are described in the book “AutonomousElectrical Stimulators for Organisms of Humans and Animals” Pekarsky V.V. et al., SMU, Tomsk 1995), i.e. having restored motor evacuativefunction of GIT or achieved some other effect of electrical stimulationthe control unit 18 switches off the pulse series or changes theirparameters. A change of parameters of stimulating pulses from averagestatistical is made when the reaction of GIT organs on electricalstimulation differs from average statistical characteristics, registeredfor all the period of using electrical GIT stimulators. For example,when having still low motor activity of GIT organs after certain periodof stimulation by pulses with average statistical characteristics(current, voltage) it is possible to increase gradually current orvoltage of electrical stimulation until a positive effect is achieved.After switching-off pulses or changing their parameters the control unit18, working under program of micro-controller 80, continues monitoringGIT activity, i.e. the signals coming from internal organs to thereceiver device 22 and can, in response to the program, switch on adefined mode of electrical stimulation, and/or connect additionalelectrodes one by one or in some combination depending on a givenprogram of treatment. Thus, for example, it is possible to carry outelectrical GIT stimulation with biocontrol, as it is described by M. A.Sobakin and V. A. Shepelev in their work “Equipment and Methods forElectrical Stomach Stimulation Using a Feedback Principle”,/Experimental Surgery and Anesthesiology/—1973 2, p.26. The receiverdevice 22 registers GIT biopotentials and at each phase of a positivehalf-wave of GIT biopotentials the control unit 18 sends stimulatingpulses to the M-electrodes 30 a of the electrical stimulator 10. Usingthe receiver device 22, with a pH-sensor (acidity sensor), it ispossible to track the moving of the electrical stimulator from a stomachwith sour environment to bowels with alkaline environment. This isnecessary to know for the prescription of electrical stimulation and/orintroducing microelements and medicinal preparations into certainsections of GIT. For patients having gastritis, the registration ofacidity decrease from pH=1.9 to pH=5.5 is indicative of positive effectachieved from electrical stimulation (see “Autonomous ElectricalStimulators for Organism of Humans and Animals”, Pekarsky V. V. et al,SMU, Tomsk 1995, p.68). When the temperature sensor registers anincrease in temperature of GIT that is higher than a level ofcontra-indication for application of electrical stimulation (ibid.,p.6), the control unit 18 can, operating under the given program,automatically switch off the electrical stimulator 10. In case of adecrease of GIT activity lower than some defined level, the control unit18 switches on a pulse series and sends them to the M-electrodes 30 a,which are in contact with the GIT walls. The electrical pulses,influence the bowels walls, and cause reciprocal reaction in the form ofa peristaltic wave, which moves the electrical stimulator 10 and othercontents of the intestine to its diastolic section, where next pulseseries is generated and the process repeats.

If, when the capsule is passing certain GIT sections, and there arisepain or muscle convulsions sensations, a patient has an opportunity toswitch off the electrical stimulator 10 or to change the parameters ofits pulses (to reduce a current or a voltage) using an externaltransmitter (not shown). The external transmitter may not even be adevice, for example, the patient may send switch-on or switch-offsignals by clapping himself on abdominal muscles to send a signal to thereceiver device 22. This allows removal of muscle convulsions and painof the patient, thus reducing negative side-effects from use of theoffered autonomous electrical GIT stimulator 10. There is also theopportunity for a doctor to monitor the signals received from internalorgans and transmitted by the signal transmitter to an external receiverin order to obtain more exact diagnostics and treatment.

The electrical stimulator 10 contains the receiver device 22 forreceiving signals from internal organs, and sensors for registering andsending signals of the physiological parameters of motor-evacuativefunction and condition of the GIT organs. The receiver device 22 canalso receive externally transmitted signals. The receiver device 22 cancontain a sensor of pressure, a sensor of pressure gradient, pH sensor(acidity sensor), a sensor of background (acoustic) activity, a sensorof biopotential a sensor of conductivity (impedance) of adjoiningtissues, a sensor of temperature, etc. The electrical stimulatorelectrodes, both M-electrodes 30 and P-electrodes 46, can be used forelectrodes of the sensor of conductivity of adjoining tissues and forthe sensor of biopotential—in which case it is possible to connect theelectrodes directly to inputs of the control unit 18 in order to measureconductivity and biopotentials of adjoining tissues. The receiver device22 contains also a sensor such as an inductor, an acoustic or ultrasoundsensor, etc., for receiving external signals or commands sent by anexternal transmitter. The signals or commands can be transmitted: byradio frequency transmission, inductively, by sound, by ultrasound etc.It is possible to have one sensor for receiving signals from both theinternal organs and from the external transmitter (e.g., a sound oraudio frequency sensor). 1 to N outputs of the receiver device 22 areconnected to 1 to N inputs of the control unit 18, and the circuitry ofthe receiver device 22 can comprise an amplifier converter, able toamplify and convert the signals from the sensors within the limits,required for reliable work of the control unit 18.

1 to M outputs of the control unit 18 are connected to M-electrodes 30.Likewise, the P-electrodes 46 are connected to separate 1 to P outputsof the control unit 18. The control unit 18, under hardwired control orprogram algorithm, can switch on or off the pulse series sent to theM-electrodes 30, and additionally change the polarity of the pulseseries (bipolarly or monopolarly), including various phase shifts ofphases. The control unit 18 can also send pulse series to theP-electrodess 46, and change pulse parameters (current, voltage,duration, frequency, phase of pulses, form, on off time ratio etc.).These changes can be made in response to signals from the internalorgans and/or external transmitted signals controlled by the patient orby the doctor. Providing the electrical stimulator 10 with replaceableP-electrodes 46 allows the patient to use P-electrodes 46 with variouscoatings of microelements or medicinal preparations for differentpurposes, depending on a specific application of the electricalstimulator 10, or on a doctor's prescription or recommended therapeuticprogram. The electrodes of the offered stimulator 10 should be made fromnon-toxic, biologically neutral materials, which are stable in anaggressive environment (for example, from stainless steel). Also,certain electrodes can be integral to the casing 12 as a constructiveelement, or can be designed as a conducting film covering the casing 12of an electrically insulated capsule. The form of the electrodes shouldprovide for good contact with adjoining muscle tissues of the GIT. Thecasing 12 of the electrical stimulator should be streamline, suitablefor safe application orally, rectally, or for vaginal use. The casing 12should provide tightness both of the electronic circuit, and of thepower source 4, and must be made from a non-toxic, biologically neutralmaterial (i.e., food impervious).

The electrical GIT stimulator 10 contains the signal transmitter 14,having 1 to N inputs which are connected to 1 to N outputs respectivelyof the receiver device 22, and an input connected to a separate outputof the control unit 18. The information transmitted from the transmitter14 is accepted by an external receiver (not shown) for medicalsupervision and diagnostics. The same channels may be used for sendinginformation to external transmitter and receiving external commands fromit; possibly the same sensor may be utilized—for example an ultrasonicsensor or acoustic microphone can generate ultrasonic or soundoscillations, which can be accepted by the external receiver, in thesame way it is possible to use an inductive coil.

In an embodiment having external control (FIG. 3), the control unit 18contains a filter circuit 50, the input of which is connected to anoutput of the receiver device 22. The output of the filter circuit 50 isconnected to an input of the amplifier limiter 56, the output of whichis in turn connected to an M-electrode 30 a of the electrical stimulator10, and its common buss or ground is connected to another M-electrode 30a. The filtering circuit 50 separates an effective signal coming from anexternal transmitter, and the amplifier limiter 56 amplifies andrestricts the parameters of pulse series within required limits (forexample, current no more than 10 mA).

The embodiment of the control unit 18 (FIG. 4) having GIT activitytracking and external control comprises an integrator 52, controlling apulse series generator 60, which, for example, may be a series circuitof multi-vibrators forming pulse series. An example of such a pulsegenerator is a microcircuit I106A, utilized in autonomous electrical GITstimulation. The control unit 18 can operate under a hardwiredalgorithm, where, having achieved high GIT motor activity the pulses(voltage), the receiver device 22, registering characteristics of GITmotor activity (for example, pressure or biopotentials) sends an inputsignal to the integrator 52. The output of integrator 52 is connected toan input of the threshold device (comparator) 54. When high GIT motoractivity is sensed, the voltage at the output of the integrator circuit52 reaches a threshold level and the threshold circuit 54 switches offthe pulse series generator 60 by way of the first input to the “OR”circuit 58, an output of which is connected to the control input of thepulse series generator 60. Upon a decrease of GIT motor activity, thevoltage at an output of the integrator 52 is reduced below the thresholdlevel and the threshold circuit 54 switches on the pulse seriesgenerator 60. In this embodiment, a first filtering circuit 62 separatesa switch-on signal of the electrical stimulator 10, and a secondfiltering circuit 63 separates a switch-off signal of the stimulator 10.Their outputs are connected respectively to the Set and Reset input ofthe RS trigger circuit 66. The output of the trigger circuit 66 isconnected to a second input of the “OR” circuit 58. Upon receipt fromthe second output of the receiver device 22 of a signal from an externaltransmitter to switch-on or switch-off the electrical stimulator 10, thecorresponding filtering circuit 62 or 63 sets or resets the RS triggercircuit 66, and through the second input of the “OR” circuit 58 switcheson or off the pulse series generator 60.

In the preferred embodiment of FIG. 5, the control unit 18 is embodiedas a micro-controller 80, which comprises a microprocessor, program anddata memory, analog to digital converters, digital to analog converters,discrete inputs/outputs, and timer (not shown). Examples foraccomplishing such a micro-controller include microcircuits PIC16!71 ofthe Microchip firm, 83!51GB or 87C196KB of the Intel firm (see thereference book “One crystal micro-ECM” Moscow: MIKAP, 1994, p. 391). Thesignals from internal organs and/or an external transmitter from 1 to Noutputs of the receiver device 22 come through amplifiers 82 to 1 to Nanalog-digital inputs of the micro-controller 80. The responseparameters of how the algorithms of the micro-controller 80 react onreceiving these signals, are input into the micro-controller 80 with thehelp of a program. The program is installed in the micro-controller 80either at the stage of manufacturing, or at the stage of pre-sellingpreparation, or directly by the consumer before use. In this embodiment,the M-Substitute electrode 30 a of the electrical stimulator 10 forcommunicating pulse series to the GIT organs are also used for sensingbiopotential. The biopotential signals from an M-electrode 30 a passthrough the amplifier 20 to the 1st analog-digital input of themicro-controller 80. The signal sensor of the external transmitter iscombined with the signal transmitter connection 36, which is carried outas an acoustic microphone, output of which through an amplifier 82 isconnected to N analog-digital input of the micro-controller 80. For theelectrical stimulation of adjoining tissues, M-electrodes 30 areconnected 1 to M outputs of the micro-controller 80. AdditionalP-electrodes 46 are connected separate 1 to P outputs of themicro-controller 80.

INDUSTRIAL APPLICABILITY

The offered electrical GIT stimulator 10, in comparison withuncontrollable autonomous electrical GIT stimulators, reduces oreliminates side-effects, such as a pain and muscle convulsions, causedby the passage of the electrical stimulator 10 through certain GITsections. The offered stimulator 10 also improves treatment efficiencyowing to the ability to select exact electrical stimulation parameters,and to select exact microelements or medicinal preparations dose to thespecific GIT section by an electrochemical means. Providing replaceableelectrodes allows treatment of patients differentially, i.e., toprescribe electrodes preparations with one or another coating ofmicroelements or medicinal preparations and their combinations,depending on character of disease. Also the offered stimulator 10 iseconomically favorable to the consumer, since there is an opportunity tobuy separately for the stimulator 10 replaceable preparation electrodeswith various coatings of microelements or medicinal preparations under aprescription of the doctor, or under recommendations of medicalprograms, depending on character of application of the electricalstimulator 10. There is also an option for supervision by the treatingdoctor of the condition of the patient based on signals coming frominternal organs and transmitted by the signal transmitter 14 to anexternal receiver. The offered electrical GIT stimulator 10 can besuccessfully applied to treatment and prevention of various diseases inabdominal surgery (post operating paresis, peritonitis, gall systemspathology, complicated forms of stomach ulcer and duodenum diseases), inintensive therapy and reanimation of persons with acute poisonings, fortreatment of therapeutic type diseases (gastritis, non complicatedstomach ulcer and duodenum diseases, chronic opistorhozes, disease ofgall ways and large intestines, chronic constipation). The offeredelectrical GIT stimulator 10 does not require unique technologies and isrealized on an integrated components basis using standard technologiesof hybrid integrated circuits.

After description of embodiments of the offered invention with thereference to applied drawings it is clear, that the present invention isnot limited only by these embodiments and the various changes and updating that could be carried out by one of skill in the art without adeviation from the main problem, which is defined in applied items ofthe formula.

What is claimed is:
 1. An electrical gastro-intestinal tract stimulatorcomprising a casing with M-electrodes, the casing in the form of amedicinal capsule, containing a power source, a control unit havingoutputs which are connected to the M-electrodes, and a device forreceiving signals having outputs which are connected to N inputs of thecontrol unit, wherein the device for receiving signals further comprisessensors for sensing physiologic parameters of motor-evacuative functionand current condition of gastro-intestinal tract organs and forreceiving signals from an external transmitter.
 2. The electricalstimulator of claim 1, wherein the device for receiving signals furthercomprises at least one sensor selected from the group consisting of: asensor of pressure, a sensor of a pressure gradient, a pH-sensor, anacoustic sensor, a sensor of temperature, a sensor of signals from anexternal transmitter, a sensor of biopotential, and a sensor ofconductivity.
 3. The electrical stimulator of claim 1, furthercomprising a signal transmitter having N-inputs which are connected toN-outputs of the device for receiving signals and the control unit. 4.The electrical stimulator of claim 1, further comprising P-electrodeswith a coating of microelements or medicinal preparations.
 5. Theelectrical stimulator of claim 4, further comprising means fordemounting the P-electrodes from the stimulator.
 6. The electricalstimulator of claim 4, wherein the control unit further comprises amicro-controller having analog-digital amplifiers as inputs, inputs ofwhich amplifiers are inputs of the control unit and are connected tooutputs of the device for receiving signals, and the micro-controllerhaving M outputs being outputs of the control unit connected to theM-electrodes and to the P-electrodes of the electric stimulator.
 7. Theelectrical stimulator of claim 1, wherein the control unit furthercomprises a filtering circuit having an input which is an input of thecontrol unit connected to an output of the device for receiving signalsand having an output connected to an input of an amplifier-limitercircuit, and the amplifier-limiter circuit having an output which is anoutput of the control unit and is connected to a first of saidM-electrodes of the electrical stimulator and a common buss connected toa second of said M-electrodes of the electrical stimulator.
 8. Theelectrical stimulator of claim 1, wherein the control unit furthercomprises an integrator having an input which is a first input of thecontrol unit and is connected to a first output of the device forreceiving signals and having an output connected to an input of athreshold circuit, the threshold circuit having an output connected to afirst input of an “or” circuit, the “or” circuit having an outputconnected to a control input of a pulse series generator, the pulseseries generator having outputs which are outputs of the control unitand are connected to the M-electrodes, a first and a second filteringcircuits having a common input which is a second input of the controlunit connected to a second output of the device for receiving signalsthe first filtering having an output connected to a set input of anRS-trigger circuit and the second filtering having an output connectedto a reset input of the RS-trigger circuit, and the RS trigger circuithaving an output connected to a second input of the “or” circuit.
 9. Anin-dwelling electrical gastro-intestinal tract stimulator systemincluding gastrointestinal tract sensors, external receivers andtransmitters and an in-dwelling electrical gastro-intestinal tractstimulator, said stimulator comprising: a casing configured in the formof a medicinal capsule and constructed to be biocompatible with thegastro-intestinal tract; an electronic stimulator circuit disposedwithin the casing, the stimulator circuit for electrically stimulatingthe gastro-intestinal tract and comprising: an electrical power sourcefor powering a control unit, a receiver device and a transmitter deviceof the stimulator circuit by means of an electrical connection, acontrol unit for controlling the stimulator circuit, the control unitelectrically connected to a set of electrical stimulator electrodes, theelectrical stimulator electrodes mounted proximate a surface of thecasing, and to the receiver device, and to a transmitter device, areceiver device for receiving signals, and having electrical connectionsfor outputting signals to the control unit and to a transmitter device,and a transmitter device being electrically connected to the receiverdevice and to the control unit, the transmitter device for sendingsignals to an external receiver.
 10. The stimulator of claim 9, whereinthe receiver device of the stimulator circuit receives at least onesignal from a sensor of a physiological parameter indicative ofmotor-evacuative function of the gastro-intestinal tract, the parameterselected from the group consisting of pressure, pressure gradient, pH,sound, temperature, biopotential, conductivity, and any other parameterindicative of gastro-intestinal tract status.
 11. The stimulator ofclaim 9, wherein the signal transmitter of the stimulator circuitreceives inputs from the receiver device and the control unit.
 12. Thestimulator of claim 9, wherein said electrodes further comprisesP-electrodes mounted proximate the surface of the casing, theP-electrodes having a coating selected from the group consisting ofmicroelements and medicinal preparations, and being electricallyconnected to the control unit.
 13. The stimulator of claim 9, whereinsaid electrodes comprises P-electrodes which are demountable.
 14. Thestimulator of claim 9, wherein the control unit of the stimulatorcircuit comprises: a filtering circuit having an input and an output,the input for receiving signals from the receiver device; and anamplifier-limiter circuit having an input, an output and a common buss,the input connected to the filtering circuit and the output connected toa first of said electrical stimulator electrode and the common bussconnected to a second of said stimulator electrode.
 15. The stimulatorof claim 9, wherein the control unit of the stimulator circuitcomprises: an integrator circuit having an input connected to a firstoutput of said electrical connections for outputting signals of thereceiver device and an output connected to an input of a thresholdcircuit; the threshold circuit having an output connected to an ORcircuit; the OR circuit having first and second inputs and an output,the first input connected to the output of the threshold circuit, thesecond input connected to an output of an RS-trigger circuit, and theoutput connected to an input of a pulse generator; a pulse generatorhaving a control-input connected to the output of the OR circuit, andoutputs connected to said set of electrical stimulator electrodes; afirst and a second parallel filtering circuits, having a common inputconnection to a second output of the receiver device, and the firstfiltering circuit having an output connected to a SET-input of theRS-trigger circuit, and the second filtering circuit having an outputconnected to a RESET-input of the RS-trigger circuit; and the RS-triggercircuit having the SET-input and RESET-input each separately connectedto the output of the first and second filtering circuits, and the outputconnected to the second input of the OR circuit.
 16. The stimulator ofclaim 9, wherein the control unit comprises: amplifiers 1 to N, eachhaving an input connected to a signal source selected from the groupconsisting of a feed-back circuit, the receiver device and thetransmitter device, and each having a digital output connected to aninput of a microprocessor; and a microprocessor, having N-inputs 1 to N,and M-outputs 1 to M and P-outputs 1 P, and the M-outputs beingconnected to said electrical stimulator electrodes, and the P-outputsbeing connected to a set of P-electrodes.
 17. The control unit of claim16, wherein the amplifiers 1 to N further comprise analog-digitalconverters.
 18. The stimulator of claim 9, wherein the receiver deviceof the stimulator circuit receives an externally transmitted signal. 19.An electrical gastro-intestinal tract stimulator device capable of beingintroduced into the gastro-intestinal tract orally or rectally orsuitable for vaginal use, comprising: a casing in the form of a capsulewith M-electrodes and P-electrodes and containing a power source; acontrol unit having N-inputs, M-outputs and P-outputs, and the M-outputsconnected to the M-electrodes, and the P-outputs connected to theP-electrodess provided with a coating of microelements or medicinalpreparations; a receiver device for receiving signals from internalorgans and an external transmitter, and having the N-outputs connectedto the N-inputs of the control unit; and a signal transmitter device forsending signals from the receiver device and the control unit to anexternal receiver for medical observation and monitoring.